Martyn Day: It is a pleasure to serve under your chairmanship today, Mr Pritchard. I am somewhat reassured by many of the Minister’s comments, and I thank him for his explanations. Much of this stuff is technical, and I hope he sees amendment 48 in a similar light. I think it would improve and strengthen the measure.
The clause does not currently set out a mechanism for the disclosure of information to devolved Administrations or bodies. For example, how will the information be disclosed, and by what means? Will it be only the Secretary of State who can disclose? In short, will the devolved Administrations be able to get the information when they want and need it, so that it ties in with the figures and statistics they are seeing and they can see patterns? It is about flexibility.
The amendment is fairly straightforward and we think it would help to strengthen and improve the Bill. I hope that the Minister agrees. We would like him to clarify whether the Government intend to leave disclosure to the discretion of the Secretary of State, on an ad hoc basis? Otherwise, what would the terms of disclosure be?

Philippa Whitford: If the Minister looks at our amendment, which is incredibly short, he will see that all it says is “at that person’s request.” We do not want to widen the list in any way at all; we are not looking to add to the list. All we are saying is that, if it is accepted that a devolved Government should be able to access this information, it should be at the request of that devolved Government. It should not be, “We will tell you every April how you’re doing,” but that if a devolved country sees a pattern emerging, it can say, “Can we request our data?” The issue is that data are to be collected centrally but not belong to the devolved nations to which they pertain. We are not trying to add anyone; we are just trying to give the devolved countries the power to request.

Order. The TV cameras are broadcasting this debate live, and I am sure the public want to see more of him than our colleagues. It would be good if he faced inwards.

Rob Marris: If the draft regulations are to pass into legislation as currently drafted, I congratulate the Government on the annual review in draft regulation 32 and its doppelgänger in draft regulation 14. They are excellent, because they actually talk about assessing the effectiveness, or otherwise, of a particular piece of legislation. That is often sorely lacking in this place, so I offer my congratulations.

Philip Dunne: I do not actually agree that there is a direct link. There is no question but that, in order to stimulate continued investment in R and D, it is appropriate for the industry to see a stable marketplace in a country as significant and important as the UK, and throughout the nations of the UK, for medicines and medical supplies. We are a large market. We spend more than £15 billion a year on pharmaceutical products, and we are also acknowledged by those companies to be a reference market for many other countries that do not have such a large or well-organised supply chain as we do. I accept that, in principle, it might be rather different if this was an emergent market.
Individual drugs are emerging through R and D programmes, but I do not think that is the same as the measures we are introducing, which are primarily designed to limit excessive abuses of pricing position, in which a company may be a monopoly supplier, in the case of the unbranded generics, for the branded products. We have a long-established procedure for recognising the recovery of R and D costs through the pricing mechanisms, and while we may not like paying for some of those branded products at the rate that we have to, we recognise that it is a competitive marketplace and, because of the cost of innovation—the cost of conducting clinical trials and so on—it is necessary to stimulate that innovation to ensure that those companies make a reasonable profit.
Promoting innovation is a high priority, not only for the Government and the NHS but for many other stakeholders in the industry. In our view, it would not be possible to quantify the contribution of the schemes in the Bill to that endeavour, for the reasons I have discussed. Trying to assess the impact on innovation is a much wider endeavour that does not just rely on price. For those reasons, I urge members of the Committee to reject the new clause.

Justin Madders: We will have to see whether those figures and estimates become reality, in particular in light of the fact that the industry has not yet seen the regulations proposed. The approach is a wider one, based not only on the impact on research and development but on the continued duty of the NHS to promote innovation and the way in which the powers will affect the availability and cost of medicines and medical supplies. I will press this to a vote.

Philippa Whitford: I beg to move, That the clause be read a Second time.
The new clause seeks to explore one of the other anomalies that was challenged through a private Member’s Bill last November but unfortunately was talked out by the Minister at that time: repurposed off-patent drugs. Those are drugs designed for a particular use that, often during their use for that condition, contribute in relation to another condition.
Today, we have had considerable talk about the need to support pharmaceutical industries and encourage research and development, but the finding of a new purpose for a drug rarely comes from the pharmaceutical industry; it is usually done at a clinical or academic level through noticing patterns in clinical practice and following those up with trials. It is therefore not really something for which the pharmaceutical industry should receive a major award financially, although naturally if more of a company’s drugs sell and it is still producing them, it will see a benefit, which is totally fair enough.
One of the concerns is that, for a medic under the General Medical Council, there is a hierarchy of what we can prescribe, and at the top of that is licensed drugs for the purpose of the licence. Below that come repurposed drugs, which are therefore not licensed for that purpose. It is specifically stated that “they do the same” is not a sufficient excuse for using an off-patent generic drug.
With some of the drugs we have, new purposes are being discovered. Some statins can reduce brain atrophy in progressive multiple sclerosis. We have, as was referred to earlier, the use of bisphosphonates to prevent metastatic breast cancer and the use of tamoxifen to try to prevent breast cancer. That Bill was partly about trying to promote the use of those drugs, because they are off-patent and cheap, but one of the concerns among the medical profession is about a drug company buying a drug, tweaking it ever so slightly and then suddenly re-releasing it as a drug for multiple sclerosis at 10 grand a day instead of sixpence. What I do not see in this Bill is a recognition of the ability of people to come back and license a drug and totally change the price or to manufacture that drug simply as a generic with a massive price.
There was a case with the drug Lyrica, which is also known as pregabalin. The commonest use of that is for neuropathic pain: people who have had nerve damage from surgery or trauma and have difficult-to-control pain. The drug was originally designed for epilepsy, and Pfizer, which makes it, managed to get a court order saying that the patent on its use for neuropathic pain would continue to 2017 and that it would sue general practitioners who prescribed it as generic. That case has run for quite a long time, and I am proud to say that GPs basically ignored that order and have used the generic, but the advice of NHS England, which still sits on the website, says that GPs must prescribe Lyrica as Lyrica, which is obviously much more expensive. Therefore, over the last year GPs have had to be sitting out there exposed, open to the threat of litigation.
That is a real concern with repurposed drugs. That profit has been earned not by pharma’s research but by the research of other people usually in the public sphere: academics and in the NHS. Again, the new clause is to raise an issue that is not covered in the Bill and to see if it has been considered at all by the Government.

Philip Dunne: I am sure that you share, Mr Pritchard, my pleasure that the Committee has had the benefit of the hon. Gentleman’s forensic scrutiny and his particular facility for not only the English language but its parliamentary use. If we had not had a new clause tabled by him we would have all gone away deeply disappointed. I am grateful to him for taking such trouble to table the new clause and to explain its intent.
I can assure the hon. Gentleman and the Committee that MRI scanners, by way of example, and all other investigative medical supplies are covered by the current definition of “medical supplies” in the 2006 Act. When looking at the definitions in the first draft of the Bill, I had a concern that we were describing products too widely. My concern was not that we would exclude specialist medical equipment but that we might include other materials used in the construction of buildings used by the health service—for example, bricks—as an object for price control, which clearly is not the intent. We looked carefully at the definitions, which is why I can say with some confidence that the hon. Gentleman’s new clause is unnecessary.
I will explain that more specifically. Section 260 of the 2006 Act makes it clear that “medical supplies” should be read in the context of medical supplies required  for the purposes of the health service. That excludes all medical supplies not destined for the health service. MRI scanners clearly are destined for and used in the health service. Secondly, section 260 provides examples of products that would be included by the term “medical supplies” and does not limit it to those products.
The Government consider that the current definition of “medical supplies” already includes the examples given by the hon. Gentleman and other investigative products and that there is no need to make the proposed amendment. We are concerned that by including further examples and trying to provide a definition that meets the hon. Gentleman’s intent, we might inadvertently find ourselves excluding other things that are in fact included within the more general description of medical supplies. The current definition is sufficiently broad to cover all medical supplies required for the purpose of the health service. Notwithstanding the hon. Gentleman’s enthusiasm, I encourage him to withdraw the amendment.